← Back to Search

Monoclonal Antibodies

Administration of BMS-986453 for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Participants in Part A and Part B Cohort 1 must have received at least 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial aims to evaluate the effectiveness of BMS-986453 in patients with relapsed and/or refractory multiple myeloma.

Who is the study for?

This trial is for people with multiple myeloma that has come back or didn't respond to treatment. They should have tried at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, and seen their disease progress within a year of the last treatment. Good organ function and physical ability (ECOG status 0 or 1) are required.Check my eligibility

What is being tested?

The study tests BMS-986453 in those with relapsed/refractory multiple myeloma. Participants will also receive Fludarabine and Cyclophosphamide as part of the treatment regimen to evaluate the effectiveness and safety of BMS-986453.See study design

What are the potential side effects?

Possible side effects from BMS-986453, Fludarabine, and Cyclophosphamide may include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver issues, kidney dysfunction, mouth sores, diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

I have had at least 3 treatments for myeloma, including specific types of medication.

Select...

My multiple myeloma has come back or is not responding to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with AEs leading to death

Number of participants with AEs leading to discontinuation

Number of participants with dose-limiting toxicities (DLTs)

+2 more

Secondary outcome measures

Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))

Complete response rate (CRR)

Duration of complete response (DOCR)

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of BMS-986453Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Cyclophosphamide

1995

Completed Phase 3

~3770

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLead Sponsor

14 Previous Clinical Trials

1,597 Total Patients Enrolled

5 Trials studying Multiple Myeloma

328 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,508 Previous Clinical Trials

3,370,293 Total Patients Enrolled

72 Trials studying Multiple Myeloma

25,157 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study currently accepting new participants?

"According to the details provided on clinicaltrials.gov, this particular clinical trial is not actively seeking participants. The initial posting of the trial occurred on January 8th, 2024 and it was last modified on December 22nd, 2023. However, it's worth noting that there are currently 795 other trials accepting enrollees at present."

Answered by AI

At how many different venues can this clinical trial be accessed?

"At present, 16 different sites are open for patient enrollment in this clinical trial. These locations include major cities such as San Francisco, Seattle, and Birmingham, along with an additional 16 other diverse areas. It is advisable to choose the clinic nearest to you in order to minimize travel requirements if you decide to participate."

Answered by AI

Has the Food and Drug Administration (FDA) granted approval for the usage of BMS-986453?

"Due to limited data supporting safety and efficacy, the administration of BMS-986453 is assigned a safety rating of 1 on a scale from 1 to 3. This assessment is based on it being a Phase 1 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

2024. "A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06153251.

All > Paid Studies Seattle > Colorado Springs